Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial.

IF 7.6 1区 医学 Q1 CLINICAL NEUROLOGY
Charles R Conway, Scott T Aaronson, Harold A Sackeim, Mark S George, John Zajecka, Mark T Bunker, Walter Duffy, Mary Stedman, Patricio Riva-Posse, Rebecca M Allen, João Quevedo, Matthew Berger, Gustavo Alva, Mohd A Malik, David L Dunner, Ivan Cichowicz, Michael Banov, Lucian Manu, Ziad Nahas, Matthew Macaluso, Brian J Mickey, Yvette Sheline, Christopher L Kriedt, Ying-Chieh Lisa Lee, Charles Gordon, Olivia Shy, Quyen Tran, Laura Yates, A John Rush
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引用次数: 0

Abstract

Background: Few treatments are available for individuals with marked treatment-resistant depression (TRD).

Objective: Evaluate the safety and effectiveness of FDA-approved adjunctive vagus nerve stimulation (VNS) in patients with marked TRD.

Methods: This 12-month, multicenter, double-blind, sham-controlled trial included 493 adults with marked treatment-resistant major depression who were randomized to active or no-stimulation sham VNS for 12 months. The primary outcome was percent time in response across months 3-12, with response defined as a ≥50 % change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS). Several secondary endpoints were evaluated.

Results: Overall, 88.4 % of participants completed the trial. Percent time in MADRS response did not distinguish active from sham VNS. However, ratings from on-site clinicians (Clinical Global Inventory-Impression [CGI-I]), patients (Quick Inventory of Depressive Symptomology-Self Report [QIDS-SR]), and offsite masked raters (Quick Inventory of Depressive Symptomology-Clinician [QIDS-C]) revealed antidepressant benefits significantly favoring active VNS. Active VNS demonstrated significantly more percent time in response on the CGI-I (P = 0.004) and QIDS-SR (P = 0.049), and significantly more percent time in partial response (PR; symptom improvement ≥30 %) on the CGI-I (P < 0.001) and QIDS-C (P = 0.006) versus sham VNS. Active VNS exceeded sham VNS in rate of dyspnea (P = 0.035), a known side effect of VNS. No new adverse events were identified.

Conclusions: Percent time in MADRS response did not distinguish the treatment groups, but on multiple instruments time in response and PR showed a positive treatment effect. VNS was found safe and effective in participants with marked TRD.

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来源期刊
Brain Stimulation
Brain Stimulation 医学-临床神经学
CiteScore
13.10
自引率
9.10%
发文量
256
审稿时长
72 days
期刊介绍: Brain Stimulation publishes on the entire field of brain stimulation, including noninvasive and invasive techniques and technologies that alter brain function through the use of electrical, magnetic, radiowave, or focally targeted pharmacologic stimulation. Brain Stimulation aims to be the premier journal for publication of original research in the field of neuromodulation. The journal includes: a) Original articles; b) Short Communications; c) Invited and original reviews; d) Technology and methodological perspectives (reviews of new devices, description of new methods, etc.); and e) Letters to the Editor. Special issues of the journal will be considered based on scientific merit.
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